Immunization Update 2013

Andrew Kroger M.D., M.P.H.Centers for Disease Control and Prevention

American Academy of Pediatrics Connecticut ChapterDecember 3, 2013

National Center for Immunization & Respiratory Diseases

Immunization Services Division

Disclosures

No financial conflict or interest with the manufacturer of any product named during this presentation.

I will present recommendations for tetanus-toxoid, diphtheria-toxoid, acellular pertussis (Tdap) vaccine, human papillomavirus vaccine (HPV) , and influenza vaccines in an off-label manner

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Overview 2013 Immunization schedules New MMR recommendations HPV vaccine Tdap (pregnancy) Influenza vaccines Storage and handling Vaccine administration

* Citations,

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Measles-Mumps-Rubella Vaccine

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New MMR Recommendations –

Children with HIV Recommended age for 2nd dose – 4 – 6 years Definition of severe immunosuppression Recommendations for Children with perinatal HIV who

received MMR vaccine before combination Anti-retroviral Therapy (cART)

General criteria of immune/susceptible – adults

Recommendation for use of passive immunobiologics

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Severe Immunosuppression

ABSENCE OF SEVERE IMMUNOSUPPRESSION Children 5 years old or younger

CD4 T-lymphocyte percentage ≥ 15 for 6 months or longer

preferred metric CD4 T-lymphocyte counts above sliding scale

parameters for 6 months or longer (value varies by age (see text for details))

Persons older than 5 years CD4 T-lymphocyte count greater than 200 cells/mm3 for

6 months or longerPreferred metric

CD4 T-lymphocyte percentage ≥ 15 for 6 months or longerwww.cdc.gov/mmwr/pdf/rr/rr6204.pdf

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Revaccination with MMR

A revaccination dose of MMR vaccine should be given to children infected with HIV in the perinatal period who received MMR vaccine before establishment of combined Anti-retroviral Therapy (cART)

Use the same parameters for absence of severe immunosuppression Add 6 months of cART therapy prior to revaccination

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Criteria of Immunity

Physician diagnosis of measles, mumps, or rubella can NO LONGER be used as a criteria of immunity

Applicable generally to adults with no history of MMR vaccine series in childhood

Lowers the threshold for administering a dose to adults

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Post-exposure Prophylaxis for Measles

Previously two concentrations of IGIM were recommended, depending on whether the contact was immunocompromised

Now use higher concentration (immunocompromised level) for healthy contacts Dose = 0.5 mL/kg IGIM

MMR recommended for infants 6 – 12 months for post-exposure prophylaxis for measles

IGIM recommended for infants younger than 6 months for post-exposure prophylaxis for measles

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Post-exposure Prophylaxis for Measles

For immunocompromised contacts, use IGIV for post-exposure prophylaxis for measles

400 mg/kg If IGIV is being administered routinely, a

recent dose (within past 3 weeks) is sufficient to prophylax for measles exposure (i.e. another dose of IGIV not needed)

If IGSC is administered in past 2 weeks, same rule applies

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HUMAN PAPILLOMAVIRUS VACCINES (HPV)

http://www.cdc.gov/vaccines/pubs/ACIP-list.htm#hpv12

Comparing HPV VaccinesHPV4 (Gardasil) HPV2 (Cervarix)

Types 6, 11, 16, 18 16, 18

Recommendations for Females

Routine: 11-12 yrs Catch-up: 13-26 yrs

Routine: 11-12 yrs Catch-up: 13-26* yrs

Recommendations for Males

Routine: 11-12 yrsCatch-up: 13-21 yrs Immunocompromised: 11-26 yrsMSM: 11-26 yrsHIV positive: 11-26 years

Do not administer to males

Schedule 0, 1-2*, 6 mos

Route Intramuscular (IM)

*ACIP off-label recommendation13

HPV Series Completion

Significant number of girls who began the HPV series do not receive all three doses

Related factors include parents’ understanding vaccine not needed (19.1%); vaccine not recommended (14.2%); vaccine safety concerns (13.1%); lack of knowledge about the vaccine or the disease

(12.6%); daughter is not sexually active (10.1%)

MMWR 2013; 62 (No. 29) July 26, 201314

HPV Immunization Rates13-17 Years of Age

*Percentages ≥1 human papillomavirus vaccine, either HPV4 or HPV2 reported among females only (n=11,2360)

** ≥3 doses of human papillomavirus vaccine, either quadrivalent or bivalent. MMWR 2012; 61 (No. 33):1117-11123 and MMWR 2013; 62 (No. 29) July 26,

2013

HPV Vaccine 2011 2012

1 or more doses* 53.0% 53.8%

3 dose series completion **

34.8% 33.4%

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Actual and Potentially Achievable Vaccination Coverage if Missed

Opportunities Were Eliminated: NIS-Teen, 2011

Healthy People 2020 Objectives

HPV-1 coverage is among females only.Source: NIS Teen 2011; Slide courtesy Shannon Stokley (CDC/NCIRD/ISD)

84.0% of HPV-unvaccinated girls have had a missed opportunity in 2012

If these girls had received the HPV vaccine during visits when another vaccine was given, coverage with at least 1 dose of HPV could be 92.6%

MMWR 2013; 62 (No. 29) July 26, 2013

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Strategies for Increasing HPV Vaccination Rates in Clinical

Practices Recommend HPV vaccine

include HPV vaccine when discussing other needed vaccines

Integrate standard procedures assess for needed vaccines at every clinical encounter immunize at every opportunity standing orders

Use reminder and recall

Tools for improving uptake of HPV: www.cdc.gov/vaccines/teens 17

Strategies for Increasing HPV Vaccination Rates in Clinical

Practices Use AFIX (assessment, feedback, incentives,

eXchange of information)

Report to registry

HEDIS measure (Jan 2012) proportion of 13-year-old girls who have not received 3

doses

Tools for improving uptake of HPV: www.cdc.gov/vaccines/teens 18

HPV Provider Resource

http://www.cdc.gov/vaccines/vpd-vac/hpv/default.htm19

Pertussis

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Tdap Vaccines

2 vaccines available licensed for different age groups

Boostrix (GlaxoSmithKline) NEW! Approved for persons 10 years of age and older Single dose

Adacel (sanofi pasteur) Approved for persons 11-64 years of age Single dose

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General Principles for Useof Tdap Tdap preferred to Td to provide

protection against pertussis

Both vaccines approved as a single dose

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Tdap-naïve Women and Pregnancy

• Providers of pregnant women should recommend Tdap to their patients

• This strategy is preferred to cocooning, but if Tdap cannot be given in pregnancy it can be given in postpartum period

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Pregnancy and Repeat Tdap Doses

• Pregnant women should receive Tdap with each pregnancy

• Ideal time is 27-36 week gestational age

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Influenza

http://www.cdc.gov/flu/professionals/acip/2013-interim-recommendations.htm

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Influenza Vaccines for 2013-14

Inactivated (IIV, formerly TIV) intramuscular or intradermal trivalent (IIV3, ccIIV3, RIV3) or quadrivalent

(IIV4) A/H1N1, A/H3N2, one or two B strains

duration of immunity one year or less

Live attenuated influenza vaccine (LAIV) nasal spray quadrivalent only (LAIV4) duration of immunity at least one year

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New Influenza Vaccines 2013-14

Product IndicationsType/

antigens Presentation Route

Fluarix 3 yrs and older IIV4 MF Syringe IM

FluLaval 3 yrs and older IIV4 MD Vial IM

FluBlok 18 thru 49 yrs RIV3 SD Vial IM

Flucelvax18 yrs and

older IIV3 MF Syringe IM

FluMist2 thru 49 yrs healthy; not

pregnantLAIV4 MF Sprayer

Intranasal

Fluzone6 months and

older IIV4MF Syringe

IMSD Vial 27

Influenza Vaccine Presentations 2013-2014

Name Manufacturer Age Range # Antigens Presentation Route Type/Abbrev.

Afluria CSL 5 and older TrivalentPre-Filled Syringe

IMInactivated

IIV3Multi-Dose Vial

Fluarix GSK 3 and olderTrivalent

Pre-Filled Syringe

IMInactivated

IIV3

QuadrivalentPre-Filled Syringe

IMInactivated

IIV4

FluBlokProtein

Sciences18 - 49 Trivalent

Single-Dose Vial

IMRecombinant

RIV3

Flucelvax Novartis 18 and older TrivalentPre-Filled Syringe

IMCell Culture

ccIIV3

FluLaval GSK 3 and olderTrivalent Multi-Dose Vial IM

InactivatedIIV3

Quadrivalent Multi-Dose Vial IMInactivated

IIV4

FluMist Medimmune 2 - 49 QuadrivalentPre-Filled Sprayer

Intranasal (IN)

Live Attenuated

LAIV4

Fluvirin Novartis 4 and older TrivalentPre-Filled Syringe IM

InactivatedIIV3

Multi-dose Vial

FluzoneSanofi Pasteur

6 months and older

TrivalentQuadrivalent

Pre-Filled Syringe

IMInactivated

IIV3 and IIV4Single-Dose

VialMulti-Dose Vial

Fluzone High-Dose

Sanofi Pasteur

65 and older TrivalentPre-Filled Syringe

IMInactivated

IIV3

Fluzone Intradermal

Sanofi Pasteur

18 - 64 TrivalentPre-Filled

Microinjection System

Intradermal(ID)

InactivatedIIV3

Available at http://www.cdc.gov/flu/protect/vaccine/vaccines.htm

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Choice of Influenza Vaccine

The choice should primarily be driven by the age-indication and contraindications and precautions

Where more than one type of vaccine is appropriate and available, ACIP has no preferential recommendation for use of any influenza vaccine product over another Quadrivalent vs trivalent High-dose vs standard dose IIV vs LAIV in any age group for whom either is

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Influenza Vaccination Schedule

Annual vaccination for persons 6 months of age and older without contraindications or precautions

IIV dosage varies by age 6 months through 35 months 0.25 ml 3 years and older 0.5 mL

Administer 1 dose per season to persons 9 years of age and older

Some children 6 months through 8 years of age will need 2 doses

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One Dose or Two? Vaccine for Children 6 Months Through

8 Years

Children aged 6 months through 8 years require 2 doses in the first season they are vaccinated

If previously vaccinated, need to have received 2009(H1N1)-containing vaccine (2009 monovalent, or 2010-11, 2011-12, or 2012-13 seasonal vaccines)

This season (as the last), there are two acceptable approaches for determining the number of doses

These differ in whether or not vaccination history prior to the 2010-2011 season is considered

MMWR 2012; 61(32):613-618.31

Dose Algorithm for 6 Months Through 8 Year Olds

MMWR 2012; 61(32):613-618.

* Doses should be administered a minimum of 4 weeks apart.

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Dose Algorithm for 6 Months Through 8 year olds,

2013-2014 season—Alternative Approach

If vaccination history before 2010–11 is available If child received

2 or more seasonal influenza vaccines during any previous season, And at least 1 dose of a 2009(H1N1)-containing vaccine (monovalent

2009(H1N1) or 2010-11, 2011-12 or 2012-13 seasonal vaccine), Then the child needs only 1 dose in 2013–14

Need only 1 dose of vaccine in 2013–14 if : ≥2 doses of seasonal influenza vaccine since July 1, 2010; or ≥2 of seasonal influenza vaccine before July 1, 2010, and ≥1 dose of

monovalent 2009(H1N1) vaccine; or ≥1 dose of seasonal influenza vaccine before July 1, 2010, and ≥1 dose

of seasonal influenza vaccine since July 1, 2010.

MMWR 2012; 61(32):613-618.33

Influenza Vaccination for Persons with

Egg Allergies—2013-14

Can the individual eat lightly cooked egg (e.g., scrambled egg) without reaction?*†

After eating eggs or egg-containing foods, does the individual experience ONLY hives?

After eating eggs or egg-containing foods, does the individual experience other symptoms such as:

Cardiovascular changes (e.g., hypotension)

Respiratory distress (e.g., wheezing)

Gastrointestinal (e.g., nausea/vomiting)

Reaction requiring epinephrine Reaction requiring emergency

medical attention

Administer vaccine per usual protocol

Yes

Administer RIV3, if patient aged 18 through 49 yrs.;

OR

Administer IIV

Observe for reaction for at least 30 minutes following vaccination

No

Administer RIV3, if patient aged 18 through 49 yrs.;

OR

Refer to a physician with expertise in management of allergic conditions for further evaluation

Yes

Yes

No

ACIP recommendation, publication pending 34

Influenza Vaccination for Persons with Egg Allergies—2013-14: Second

Modification

Addition of the following: For individuals with no known history of exposure to

egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing: Consultation with a physician with expertise in the

management of allergic conditions should be obtained prior to vaccination

Alternatively, RIV3 may be administered if the recipient is 18 through 49 years of age

ACIP recommendation, publication pending 35

Storage and Handling

CDC recommends vaccines be stored in stand-alone refrigerator and freezer units rather than combination units The refrigerator compartment of a

combination unit may be used to store refrigerated vaccines and a separate freezer unit to store frozen vaccines

Storage units should have Enough room to store the year’s

largest inventory without crowding; Sufficient room to store water

bottles (refrigerator) or frozen coolant packs (freezer);

Frost free or automatic defrost units are preferred

www.cdc.gov/vaccines/recs/storage/toolkit/default.htm

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Storage Unit Guidance CDC does not recommend

use of a “dormitory-style” unit for ANY vaccine storage including temporary storage– Dorm-style = freezer

compartment with no exterior door or thermostat controls

– Increased risk of exposing vaccines to freezing temperatures

– NIST studies have shown there is no “good” vaccine storage area in a dorm-style unit

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Updated Thermometer Recommendations

CDC recommends using a calibrated, digital thermometer with a biosafe glycol-encased probe or a similar temperature buffered probe These more accurately reflect the temperature of the

vaccine vial Place the probe with the vaccine in the part of the unit

where recommended storage temperatures are best maintained

Probes should be detachable from the digital display

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Storage and Handling Practices

Storage unit temperatures should be read and documented twice each workday

The min/max temperature should be read and documented once per workday preferably in the morning

Stored temperature monitoring data should be downloaded and reviewed weekly

Weekly review of vaccine expiration dates and rotation of vaccine stock

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Vaccine Administration Errors

Vaccine Error

Any preventable event that may cause or lead to inappropriate use of a vaccine or cause patient harm

No one wants to make an error

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Rights of Medication Administration

Right patientRight vaccine and diluentRight time (age, interval, expiration

time/date)Right dosageRight route (correct needle gauge and

length and technique)Right siteRight documentation

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Vaccine Route

Oral Intranasal

Subcutaneous Intramuscular

Intradermal

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Staff Training and Education

All personnel who administer vaccines (permanent and temporary) should receive comprehensive, competency based training before administering vaccines Providers need to validate staff’s knowledge and skills with a skills checklist

Integrate training into new staff orientation annual education requirements when vaccine administration recommendations

are updated or when new vaccines are added

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Thank You Email: nipinfo@cdc.gov

CDC-INFO Website www.cdc.gov/info

Website:www.cdc.gov/vaccines

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